MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITHOUT FLOW S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7024-24
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on a picture received and one product returned.The complainant returned units were visually inspected.The sample has a flash in the square arch of the housing; thus, the failure mode reported is confirmed.The molding tool was repaired, and a picture of the defect was added for operators to be aware of and inspect for the condition.A device history review was conducted which indicated all inspections were completed and root cause analysis was conducted by supplier.
Event or Problem Description
It was reported that there was difficulty in inserting cassettes onto pump tried several pumps without success.No patient injury was reported.
Additional Manufacturer Narrative
While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-08134 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIRS WITHOUT FLOW S
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14332536
• Report Number: 3012307300-2022-08134
• Device Sequence Number: 15019113
• Product Code: FPA
• UDI-Device Identifier: 10610586019852
• UDI-Public: 10610586019852
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2025
• Device Model Number: 21-7024-24
• Device Catalogue Number: 21-7024-24
• Device Lot Number: 4025942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0148-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown